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Last Updated: April 17, 2024

Ethinyl estradiol; levonorgestrel - Generic Drug Details

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What are the generic drug sources for ethinyl estradiol; levonorgestrel and what is the scope of freedom to operate?

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-five branded drugs marketed by Agile, Glenmark Generics, Avion Pharms, Lupin Ltd, Novast Labs, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Dr Reddys Labs Sa, Aurobindo Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Sun Pharm, Exeltis Usa Inc, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, Hetero Labs, Naari Pte Ltd, and Vintage Pharms Llc, and is included in seventy-six NDAs. There are eight patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; levonorgestrel has one hundred and eight patent family members in twenty-eight countries.

Twenty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ethinyl estradiol; levonorgestrel

International Patents:	108
US Patents:	8
Tradenames:	55
Applicants:	26
NDAs:	76
Finished Product Suppliers / Packagers:	26
Clinical Trials:	58
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ethinyl estradiol; levonorgestrel
DailyMed Link:	ethinyl estradiol; levonorgestrel at DailyMed

Recent Clinical Trials for ethinyl estradiol; levonorgestrel

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Parexel	Phase 1
Merck Sharp & Dohme LLC	Phase 1
University of Washington	Phase 1

See all ethinyl estradiol; levonorgestrel clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	0.03MG,0.01MG; 0.15MG,N/A	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ethinyl estradiol; levonorgestrel

Drug Class	Estrogen Progestin Progestin-containing Intrauterine System Progestin-containing Intrauterine Device
Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; LEVONORGESTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALCOLTRA	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg	208612	1	2020-07-14
QUARTETTE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg	204061	1	2013-07-10
LOSEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg and 0.01 mg	022262	1	2009-11-16
SEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg/0.01 mg	021840		2008-01-22
LYBREL	Tablets	ethinyl estradiol; levonorgestrel	0.09 mg/0.02 mg	021864	1	2007-10-05
SEASONALE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg	021544		2004-03-29

US Patents and Regulatory Information for ethinyl estradiol; levonorgestrel

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	MINZOYA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	217087-001	Feb 15, 2024	AB3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glenmark Generics	ASHLYNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203163-001	Feb 23, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	LEVORA 0.15/30-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	073594-001	Dec 13, 1993	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ethinyl estradiol; levonorgestrel

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Try a Trial	⤷ Try a Trial
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	⤷ Try a Trial	⤷ Try a Trial
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ethinyl estradiol; levonorgestrel

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Country	Patent Number	Title	Estimated Expiration
Hungary	S1800033		⤷ Try a Trial
Canada	2692884	DISPOSITIF D'ADMINISTRATION DERMIQUE AVEC UN JOINTIN SITU (Dermal delivery device with in situ seal)	⤷ Try a Trial
Brazil	PI0814697	dispositivo de liberação dérmica com uma vedação no local	⤷ Try a Trial
China	101626760	Methods of hormonal treatment utilizing ascending-dose extended cycle regimens	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	93156	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	C 2015 029	Romania	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0771217	CA 2006 00038	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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